NEW YORK – The Manchester University NHS Foundation Trust (MFT) said Thursday that it will use £1.4 million ($1.77 million) in UK government funding to support a two-year study across the UK of Genedrive's point-of-care pharmacogenomic test to prevent antibiotic-induced hearing loss in newborns.
MFT said that the money from the National Institute for Health and Care Research (NIHR) and the Office for Life Sciences will support research across 14 National Health Service neonatal units in England, Scotland, Wales, and Northern Ireland. Genedrive has been developing its MT-RNR1 ID Kit as a rapid bedside test for the m.1555A>G variant in MT-RNR1 that is connected with predisposition to hearing loss from treatment with gentamicin.
"The PALOH-UK study will demonstrate how the test can be used in a timely way to ensure babies get a safe, effective antibiotic without affecting normal clinical practice, on a much larger scale," John McDermott, clinical geneticist at MFT, said in a statement.
The test is performed with a cheek swab sample with results provided in about 26 minutes. MFT said that about one in 500 babies carries the m.1555A>G gene variant, and about 100,000 babies in the UK are treated with gentamicin each year.
The test had been developed in 2020 at an MFT facility, Saint Mary's Hospital in Manchester, as part of the Pharmacogenetics to Avoid Loss of Hearing (PALOH) study. MFT rolled out the test to its hospitals in 2022 and 2023. Through October, the test has prevented hearing loss in 11 newborns among 4,000 tested, the MFT said.
Early last year, the UK's Institute for National Health and Care Excellence (NICE) recommended adoption of the MT-RNR1 ID Kit by the NHS.
Genedrive CEO Gino Miele added that the funding award will help to address evidence gaps that had been identified by NICE. "We … look forward to working with all partners across the UK to progress implementation of this world's-first rapid genetic test in neonatal settings, positively impacting patient outcomes and healthcare finances," he said.